Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
66673–66696 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 18, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM
K050076 · LON
bioMerieux, Inc.
Microbiology · 37d
Cleared Feb 18, 2005
ROC LUMBAR PLATING SYSTEM
K050078 · MNH
Alphatec/Nexmed
Orthopedic · 36d
Cleared Feb 18, 2005
D-STAT RADIAL HEMOSTATIC BAND
K050133 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 28d
Cleared Feb 18, 2005
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
K050187 · FTL
Sofradim Production
General & Plastic Surgery · 22d
Cleared Feb 18, 2005
MAGNETOM SYMPHONY A TIM SYSTEM
K050199 · LNH
Siemens Medical Solution
Radiology · 21d
Cleared Feb 18, 2005
AGFA HEARTLAB CARDIOVASCULAR
K050228 · LLZ
Heartlab, Inc.
Radiology · 17d
Cleared Feb 18, 2005
MODIFICATION TO TSRH SPINAL SYSTEM
K050282 · NKB
Medtronic Sofamor Danek
Orthopedic · 11d
Cleared Feb 18, 2005
LERADO, COSCO
K050290 · IOR
Lerado Oversea Ltd. Twn Branch (Bvi)
Physical Medicine · 11d
Cleared Feb 18, 2005
AQUINOX
K050314 · BTT
Smiths Medical Asd, Inc.
Anesthesiology · 9d
Cleared Feb 17, 2005
SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018
K042308 · DYB
Facile Medical, Inc.
Cardiovascular · 176d
Cleared Feb 17, 2005
BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER
K042553 · DQY
Biocardia, Inc.
Cardiovascular · 150d
Cleared Feb 17, 2005
WELL LEAD TRACHEOSTOMY TUBE
K042684 · BTO
Well Lead Medical Instruments
Anesthesiology · 141d
Cleared Feb 17, 2005
MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
K042928 · MNH
U&I Corp.
Orthopedic · 118d
Cleared Feb 17, 2005
DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT
K042957 · HIS
Ssl Americas
Obstetrics & Gynecology · 113d
Cleared Feb 17, 2005
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
K043100 · MBF
Biomet, Inc.
Orthopedic · 100d
Cleared Feb 17, 2005
SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200
K043379 · OXO
Shimadzu Corp.
Radiology · 71d
Cleared Feb 17, 2005
RESOFIX BIOABSORBABLE EXPANSION BOLT
K043411 · HTN
Resofix, Inc.
Orthopedic · 69d
Cleared Feb 17, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16...
K043545 · LRG
Dade Behring, Inc.
Microbiology · 56d
Cleared Feb 17, 2005
VITEK 2 COMPACT
K050002 · LON
bioMerieux, Inc.
Microbiology · 45d
Cleared Feb 17, 2005
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K050117 · KWQ
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Feb 17, 2005
FUKUDA DENSHI MODEL UF-850XTD
K050363 · IYN
Fukuda Denshi USA, Inc.
Radiology · 3d
Cleared Feb 16, 2005
PERSONAL INJECTOR
K033696 · KZH
Union Medico Aps
General Hospital · 449d
Cleared Feb 16, 2005
VARIAN NASOPHARYNX APPLICATOR
K042360 · JAQ
Varian Medical Systems, Inc.
Radiology · 169d
Cleared Feb 16, 2005
SURGICAL FACE MASK
K043199 · FXX
Hong YA Non-Woven Products Co., Ltd.
General Hospital · 90d